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Design and analysis of non-inferiority trials

Author: Mark D Rothmann; Brian L Wiens; Ivan S F Chan
Publisher: Boca Raton, FL : Chapman & Hall/CRC, ©2012.
Series: Chapman & Hall/CRC biostatistics series; Chapman & Hall/CRC biostatistics series.
Edition/Format:   Print book : EnglishView all editions and formats
Database:WorldCat
Summary:
"The increased use of non-inferiority analysis has been accompanied by a proliferation of research on the design and analysis of non-inferiority studies. Design and Analysis of Non-Inferiority Trials brings together this body of research and confronts the issues involved in the design of a non-inferiority trial. Using examples from real clinical trials, the book discusses general and regulatory issues and  Read more...
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Material Type: Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: Mark D Rothmann; Brian L Wiens; Ivan S F Chan
ISBN: 9781584888048 1584888040
OCLC Number: 701450141
Description: xvi, 438 pages ; 25 cm.
Contents: 1. What is a non-inferiority trial? --
2. Non-inferiority trial considerations --
3. Strength of evidence and reproducibility --
4. Evaluating the active control effect --
5. Across-trials analysis methods --
6. Three-arm non-inferiority trials --
7. Multiple comparisons --
8. Missing data and analysis sets --
9. Safety studies --
10. Additional topics --
11. Inference on proportions --
12. Inferences on means and medians --
13. Inference on time-to-event endpoints.
Series Title: Chapman & Hall/CRC biostatistics series; Chapman & Hall/CRC biostatistics series.
Responsibility: Mark D. Rothmann, Brian L. Wiens, Ivan S.F. Chan.
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Abstract:

Brings together a body of research and discusses the issues involved in the design of a non-inferiority trial. This book uses examples from real clinical trials, and discusses general and regulatory  Read more...

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"This important book is relevant because this type of trial is preferred when an approved treatment is available and a conventional placebo-controlled trial would be difficult to justify. These Read more...

 
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